Metabolic Syndrome and Fingertip Endothelial Dysfunction

Metabolic Syndrome Clinical Trial

Official title:

Achievement of Dietetic and Exercise Therapy Evaluated by Self-assessment Score Significantly Improved Endothelial Dysfunction in Patients With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007227
• Other study ID #: 743EndothelialMetsyd
• Status: Completed
• Phase: N/A
• First received: November 2, 2009
• Last updated: September 25, 2013
• Start date: August 2006
• Est. completion date: December 2011

Study information

• Verified date: September 2013
• Source: Kumamoto University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Life-style intervention with dietetic and exercise therapy is an important fundamental approach to patients with metabolic syndrome (MetSyd) which may cause endothelial dysfunction leading to cardiovascular events. We investigated whether the life-style modification by dietetic and exercise instruction could improve endothelial dysfunction assessed by a new non-invasive and automatic device; digital reactive hyperemia peripheral arterial tonometry (RH-PAT).

Description:

Outline of methods RH-PAT was measured in high-risk patients under 70 years old. The MetSyd was defined according to guidelines of the National Cholesterol Education Program Third Adult Treatment Panel (NCEP - ATP III). We instructed all MetSyd patients about the dietetic and exercise therapy according to the Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases. we conducted a questionnaire survey of the self-assessment for dietetic and exercise instruction program, respectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Under 70 years old and preserved left ventricular systolic function (left ventricular ejection fraction = 50%)

Exclusion Criteria:

• Severe valvular heart disease

• Atrial septal defect

• Myocarditis

• Cardiomyopathy

• Active inflammatory diseases

• Pulmonary hypertension

• Chronic kidney disease on hemodialysis

• Advanced hepatic disease

• Leukemia

• Schizophrenia; AND

• Cerebrovascular disease and residual hemiplegia.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Other:
• Lifestyle instruction
Instruction dietetic and exercise therapy

Locations

Country	Name	City	State
Japan	Kumamoto University Hospital	Kumamoto

Sponsors (1)

Lead Sponsor	Collaborator
Kumamoto University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial function assessed by RH-PAT		About 1 year later	No
Secondary	Metabolic status including waist circumference		About 1 year later	No